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The purpose of the Central Regulatory Registration (CRR) Associate role is to manage a portfolio of molecules/products for global regulatory registrations in major markets across the products’ lifecycle from candidate selection through product withdrawal. This person will have the responsibility to create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. The Associate collaborates with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines. The Associate is expected to provide business process knowledge and leadership to customers to resolve publishing issues and drive on time submissions The Associate also works closely with Regulatory Associates and Regulatory Scientists to manage information from regulatory agency interactions to ensure appropriate tracking of project timelines, pending approvals, and commitments. The Associates work involves technical, cross-functional processes in an environment of critical time frames and potentially changing priorities, therefore, a strong emphasis is placed on teamwork, leadership, communication, and self-management.
Functional and Technical Expertise
Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
Demonstrate in-depth understanding of ICH CTD format/style requirements and evolving US/OUS agency standards/trends. Apply knowledge to manage a variety of complex submissions
Provide publishing to influence strategies of upstream contributors/vendors to enable successful implementation with minimal impact to resources and supply chain.
Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labeling to deliver the submission.
Understand, log, and manage Incoming Correspondence from and all Records of Contact with the FDA to enable rapid and accurate updates to RAPT and RCTT impacting project timelines and pending approvals.
Accountable as process owner of a specific process. (e.g., ROCs/IC, RAPT eFiles, Publisher Qualification, CRF/CRT, OUS Submissions, etc.) to technically evaluate, drive improvements and contribute to RQS procedures.
Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway, and LillyNet [SharePoint]) to ensure compliance. Stay up to date on system and tool upgrades.
Demonstrate in-depth understanding of complex multiple FDA forms and apply project knowledge to ensure accurate submissions.
Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission.
Coordinate with RACMC Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct.
Leverages internal and external forums to continue to develop and share regulatory and drug development expertise around electronic submission structure and content.
2. Decision Making
Make decisions based on ICH guidance and global regulations to ensure compliant submissions and to drive improvements.
Identify errors in documents from contributing authors/vendors and initiates resolution of issues/errors/discrepancies.
Participate in and understand the goals of the regulatory publishing strategies of assigned molecules.
Use molecule/product and registration knowledge to accurately assign keywords, and accurately populate/execute complex FDA Forms.
Educate and influence cross-functional DCoE, Sci Com, and Labeling consultants on submission requirements for CRFs, datasets, literature references, and labeling, to ensure alignment and reduce potential technical issues impacting submission timelines.
Lead the coordination with other publishing centers and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy.
Drive improvement in SME area with registration process owner and management and incorporates changes to job aids, Publisher Qualification program, and RQS procedures.
Influence Regulatory Scientists and/or Directors to complete and sign cover letters and forms in critical timelines to ensure on time submissions.
Drive process and influence Regulatory Associates and cross-functional partners (CMC Director) to review RAPT reports and update status of US applications per required timelines.
Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.
Identify gaps and define needs to optimize publishing processes/tools that meet agency preferred specifications and CRR submission work.
Identify molecule specific eCTDXpress publishing errors/issues and influence Regulatory Associates/authors/vendors/consultants to correct errors and coach to build capability for future submissions.
Trouble shoot compile issues and proactively collaborate cross-functionally to resolve.
Test new software updates and identify/report issues impacting publishing.
Partner with quality to help determine root cause analysis of deviations.
Facilitate efficient review of the registration by the regulatory agency.
Ensure compliance submissions are delivered on time.
Positively impact regulatory cross-functional initiatives through active participation in process improvement projects, drafting/reviewing RQS documents.
Develop procedures and Job Aids for SME area.
Initiates consultation with Regulatory Associates and Regulatory Scientists to share best practices and move towards more efficient/effective work processes.
Perform quality review of peer’s submissions to ensure accuracy/compliance and coach to improve.
Train new Submission Publishers.
Conduct submission planning for assigned portfolio by identifying publishing milestone requirements for upcoming submissions and planning/managing workload to ensure on time submissions, proactively seeking resources when needed.
Lead troubleshooting investigations for compile issues for assigned molecules.
Coordinate and communicates with Regulatory Associates to prepare for unique requirements for the molecules and plan for upcoming submissions.
Proactively review multiple document sites to assess timing of document readiness from upstream authors and work ahead to publish documents.
Serve as a single point of contact for customers (e.g., Regulatory Associates, Regulatory Scientists, authors, cross functional stakeholders) for managing the submissions in eCTDXpress backbone.
Identify, escalate, and resolve issues that may impact submissions.
Collaborate with Regulatory Associate for submission bundling opportunities.
Partner with other geographies to identify, understand, and incorporate EU and OUS agency regulations and county specific requirements to effectively influence the electronic registration plan.
Develop collaborative relationships with personnel in other Lilly functional areas (e.g. DCoE/medical, RACMC, GOLD, Quality etc.).
Manage numerous templates and working folders to keep accurate and up to date to maintain efficiency and accuracy
Minimum Qualification Requirements:
The following skills and abilities are directly related to the essential functions of the job.
Degree qualified in a related field
Three years’ experience publishing submissions using eCTDXpress.
Demonstrated project management and time management skills.
Demonstrated organization and priority setting skills: must be able to manage diverse tasks and processes.
Flexibility, ability to handle time pressures
Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and customers.
Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability
High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
Proficiency in SharePoint technology.
Proven ability to take initiative and identify issues and solutions.
General knowledge of scientific literature and library retrieval.
Ability to work well independently and as part of a team, and ability to assertively marshal the efforts of multiple contributors to projects.
Effective communication/interpersonal skills.
The individual must be able to maintain the security of confidential information.
Other Information/Additional Preferences:
This position reports functionally to a CRR Manager.
This position is office-based work at Lilly Corporate Center (LCC).
The shift for the position is Monday through Friday, 8 hours a day.
Some overtime may be required.
The statements contained in this document are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be an exhaustive list of all responsibilities, duties and skills of personnel so classified.
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